Every year in the United States, approximately 230,000 women undergo hysterectomies for removal of uterine fibroids. In addition, it has been estimated that likely another six million women in the United States with uterine fibroid symptoms prefer to suffer, rather than taking on the risks and inconveniences associated with hysterectomy, the standard treatment and a major surgery that always results in infertility. This situation is much the same in the other parts of the world where women are in need of a safe alternative to hysterectomy.
Alternatives to hysterectomy such as uterine artery embolization (in which the blood supplies to the arteries that feed the fibroids are cut off), and Myomectomy (which involves a surgical removal of the fibroid) do exist, but both these methods involve complicated surgical procedures followed by a high rate of complications and a long recovery time.
In order to address these issues, an RF ablation probe that has been used to treat tumors in the human liver by hyperthermia has been demonstrated to substantially shrink or eliminate uterine fibroids.
One such device has been disclosed in U.S. Pat. No. 6,840,935 to Lee. According to the disclosure in that patent, an ablation apparatus with multiple needles or deployable arms is inserted and positioned either proximate to or into a pelvic tumor, the location of which is further confirmed by using a laparoscope and an ultrasound machine. Either electromagnetic energy (and, potentially, other forms of energy) may be delivered through the ablation apparatus to the pelvic tumor to induce hyperthermia and ablate the tumor.
A typical device for ablating pelvic tumors is sold by Rita Medical Systems, Inc. This device consists of a plurality of resilient springy pre-curved RF ablation antennae or stylets housed in a straight lumen. The stylets are ejected in a curved configuration defined by their preformed springy shapes as they exit a sharp-tipped catheter. The deployed antennae with their particular preformed shapes thus can define variously shaped volumes by varying the configuration of the curves which are preformed into the various springy antennae.